Trial · NCT00506077
MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)
NCT00506077, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2011-03-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016). Trials, record NCT00506077. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00506077
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)
- NCT number
- NCT00506077
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 55 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Paranoid Schizophrenia
- Interventions
- MK0249, Comparator: Placebo (unspecified)
- First posted
- 2007-07-25
- Last updated
- 2015-08-03
- Results first posted
- 2011-03-07
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery. | Baseline and 4 weeks of treatment | The mean change from baseline after 4 weeks of treatment in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance. |
| Secondary | Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score | Baseline and 4 weeks of treatment | The Attention/Processing Speed Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Penn Continuous Performance Test (PCPT) and BACS battery Symbol Coding. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -91 and 91, respectively. Higher values (positive changes from baseline) indicate better performance. |
| Secondary | Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score | Baseline and 4 weeks of treatment | The Episodic Memory Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Face Memory and BACS battery Verbal Memory. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -202 and 202, respectively. Higher values (positive changes from baseline) indicate better performance. |
| Secondary | Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score | Baseline and 4 weeks of treatment | The Working Memory Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological (CNP) battery N-back test and the BACS battery Digit Sequencing test. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -122 and 122, respectively. Higher values (positive changes from baseline) indicate better performance. |
| Other | Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery. | Pre-randomization Baseline | Pre-randomization baseline values for all treatment sequences are equal because the constrained longitudinal data analysis (cLDA) model was used (Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134-148). |
| Other | Pre-randomization Baseline: Attention/Processing Speed Composite Score | Pre-randomization Baseline | Pre-randomization baseline values for all treatment sequences are equal because the constrained longitudinal data analysis (cLDA) model was used (Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134-148). |
| Other | Pre-randomization Baseline: Episodic Memory Composite Score | Pre-randomization Baseline | Pre-randomization baseline values for all treatment sequences are equal because the constrained longitudinal data analysis (cLDA) model was used (Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134-148). |
| Other | Pre-randomization Baseline: Working Memory Composite Score | Pre-randomization Baseline | Pre-randomization baseline values for all treatment sequences are equal because the constrained longitudinal data analysis (cLDA) model was used (Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134-148). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery. | Baseline and 4 weeks of treatment | Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data. | Composite T-score | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score | Baseline and 4 weeks of treatment | Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data. | Composite T-score | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score | Baseline and 4 weeks of treatment | Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data. | Composite T-score | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score | Baseline and 4 weeks of treatment | Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data. | Composite T-score | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery. | Pre-randomization Baseline | Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data. | Composite T-score | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Pre-randomization Baseline: Attention/Processing Speed Composite Score | Pre-randomization Baseline | Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data. | Composite T-score | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Pre-randomization Baseline: Episodic Memory Composite Score | Pre-randomization Baseline | Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data. | Composite T-score | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Pre-randomization Baseline: Working Memory Composite Score | Pre-randomization Baseline | Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data. | Composite T-score | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery. | MK0249 | 0.4 | 95% Confidence Interval -1.2 to 2.1 | Composite T-score | |
| Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery. | Placebo | 0.5 | 95% Confidence Interval -1.1 to 2.2 | Composite T-score | |
| Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score | MK0249 | 0.5 | 95% Confidence Interval -0.4 to 1.5 | Composite T-score | |
| Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score | Placebo | 0.0 | 95% Confidence Interval -0.9 to 0.9 | Composite T-score | |
| Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score | MK0249 | 0.9 | 95% Confidence Interval -0.9 to 2.6 | Composite T-score | |
| Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score | Placebo | 0.1 | 95% Confidence Interval -1.6 to 1.8 | Composite T-score | |
| Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score | MK0249 | 0.8 | 95% Confidence Interval -1.0 to 2.6 | Composite T-score | |
| Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score | Placebo | -0.2 | 95% Confidence Interval -2.0 to 1.5 | Composite T-score | |
| Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery. | MK0249 | 40.5 | Standard Error 0.98 | Composite T-score | |
| Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery. | Placebo | 40.5 | Standard Error 0.98 | Composite T-score |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 | STARTED | MK0249 Then Placebo | 28 | |
| Treatment Period 1 | STARTED | Placebo Then MK0249 | 27 | |
| Treatment Period 1 | COMPLETED | MK0249 Then Placebo | 24 | |
| Treatment Period 1 | COMPLETED | Placebo Then MK0249 | 24 | |
| Treatment Period 1 | NOT COMPLETED | MK0249 Then Placebo | 4 | |
| Treatment Period 1 | NOT COMPLETED | Placebo Then MK0249 | 3 | |
| Washout | STARTED | MK0249 Then Placebo | 24 | |
| Washout | STARTED | Placebo Then MK0249 | 24 | |
| Washout | COMPLETED | MK0249 Then Placebo | 24 | |
| Washout | COMPLETED | Placebo Then MK0249 | 24 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | nausea | Gastrointestinal disorders | MK0249 | 4 | 52 | |
| other | nausea | Gastrointestinal disorders | Placebo | 3 | 51 | |
| other | irritability | General disorders | MK0249 | 0 | 52 | |
| other | irritability | General disorders | Placebo | 3 | 51 | |
| other | nasopharyngitis | Infections and infestations | MK0249 | 1 | 52 | |
| other | nasopharyngitis | Infections and infestations | Placebo | 2 | 51 | |
| other | alanine aminotransferase increased | Investigations | MK0249 | 1 | 52 | |
| other | alanine aminotransferase increased | Investigations | Placebo | 2 | 48 | |
| other | aspartate aminotransferase increased | Investigations | MK0249 | 0 | 52 | |
| other | aspartate aminotransferase increased | Investigations | Placebo | 2 | 48 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MK0249 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | MK0249 | 20 | 52 |
| Total, other adverse events | Placebo | 15 | 51 |
| Total, serious adverse events | MK0249 | 0 | 52 |
| Total, serious adverse events | Placebo | 0 | 51 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23523692 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| MK0249 vs Placebo: serious adverse events |
Source Trial comparisons
Tests6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Primary outcome | ConductCognition |
| Tower Planning | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| 1-Back Task | Secondary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
| Continuous Performance Test | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00506077
GET https://conductscience.org/api/trials/v1/NCT00506077/events?page=2